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CENTER FOR VETERINARY BIOLOGICS NOTICE 23-06

TO: Biologics Licensees, Permittees, and Applicants 

Directors, Center for Veterinary Biologics

Veterinary Services Management Team

FROM: Dr. Dave White

Acting Director

SUBJECT: Antimicrobial Resistance (AMR) Genes in Veterinary Biological Products

I. PURPOSE

The purpose of this notice is to outline current policy regarding the presence of 

antimicrobial resistant (AMR) genes in veterinary biologics administered to animals. This 

policy is applicable to products licensed under Title 9, Code of Federal Regulations, Part 

102.5 (9 CFR) and products produced under 9 CFR 107.1. This policy does not apply to 

diagnostics except for those administered to animals. 

II. BACKGROUND

Vaccines are often used as an example of a tool to address AMR. However, animal 

vaccines have not historically been tested for the presence of AMR genes. The spread of 

AMR has become a major public health concern, and responsible actions are required to 

mitigate any potential contributors to the issue. 

The Center for Veterinary Biologics (CVB) is currently investigating the presence of 

AMR genes in biologics, particularly those capable of vertical and lateral transfer and

regardless of the occurrence of an AMR phenotype. 

III. ACTION

All veterinary vaccines which could contain AMR genes capable of environmental spread 

will be analyzed by CVB to determine what, if any, AMR genes are present. This 

includes products licensed under 9 CFR 102.5, as well as vaccines manufactured under 

9 CFR 107.1. As per 9 CFR 107.1, any persons exempt from licensure that are shipping 

products containing live organisms must provide any information CVB may require prior 

to shipment, or at any other time deemed necessary, in order to assess the products’ 

safety and effect on the environment. CVB may request additional information from 

parties exempt from licensure. 

United States

Department of

Agriculture

Animal and Plant

Health Inspection

Service

Veterinary Services

Center for Veterinary 

Biologics

510 S. 17th Street

Suite 104

Ames, IA 50010

(515) 232-5785

FAX (515) 232-7120
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 23-06

Page 2

Concerns surrounding AMR will be incorporated into the risk/safety assessment for all 

veterinary biologics, except diagnostics unless administered to animals. For newly 

licensed products, biologics should not contain any AMR genes. Exceptions are possible 

based on CVB’s review of a complete risk assessment. CVB strongly recommends 

licensees/permittees take action to remove AMR genes from any currently licensed 

products that may contain AMR genes. In the future, CVB may consider labeling 

requirements or even market removal of products that contain AMR genes, based on a 

risk assessment. Products produced under 9 CFR 107.1 will be subject to the same 

requirements. 

CVB uses tools and databases from the National Center for Biotechnology Information 

(NCBI) to evaluate next generation sequencing and other genetic data generated from 

master seeds for the presence AMR genes. Specifically, master seed sequence data is 

analyzed using the NCBI AMRFinder tool. CVB recognizes that tools and databases 

evolve with time and that decision makers use the best data available at the time of 

testing. There may be multiple routes to replicate sequence-based testing, whether 

internally or via an external laboratory. Note: Testing identical to that conducted by CVB 

is available on a fee-for-service basis via the USDA National Veterinary Services 

Laboratories by submitting a VS 10-4 form and specifying AMR testing through whole 

genome sequencing. Please submit any questions regarding sequence-based testing to 

your reviewer.

IV: IMPLEMENTATION/APPLICABILITY

Updated policy in this Notice is effective immediately.